FDA guidance eases wearables oversight. But experts have questions about what’s next.

Scott Danzis’ commentary appeared in a MedTech Dive article about the FDA issuing a pair of guidances intended to clarify its approach to wellness devices and medical software. The updates reflect changes to the agency’s thinking about what counts as a wellness device, but also raise new questions and pose challenges to consumers.

According to Scott, the FDA’s guidance on wellness products had the most significant changes of the two. The document was focused on wearables, “which aligns with what we’ve heard from this administration more broadly.”

Another significant change in the wellness guidance was that wearables can now direct users to seek an evaluation by a healthcare provider if they get a reading outside of ranges appropriate for general wellness use. The act of telling someone to see a doctor wouldn’t make a product a medical device.

“I think it’s important that under this guidance there is an opportunity to say to the user, you should get checked out, but how you go about doing that is a tricky question,” Scott said.

With the changes, for example, if a person had a low oxygen saturation reading, their device could tell them to talk to a clinician, Scott explained.

“One of the open questions is how do you do this in a way that is appropriate but also useful?” Scott said. “If you or I were using a tool, and you get a notification saying that you should talk to your doctor, about what?”